QUATTROcare plus Spray AMERICA 2141

Basic Information

• Brand Name: QUATTROcare plus Spray AMERICA 2141
• Primary DI: EKAV100538440
• Version / Model: 1.005.3844
• Catalog Number: AMERICA 2141
• Company Name: KaVo Dental GmbH
• Labeler DUNS: 333710619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 39e10a01-090b-4ad0-b86a-9784e51c47dd

Device Description

This is a medical device.This is a medical device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFB	HANDPIECE, AIR-POWERED, DENTAL	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44690	Dental handpiece maintenance unit	A device used for the automatic internal cleaning, lubrication and maintenance of dental handpieces used in dentistry (e.g., pneumatically or electrically driven scalers, motors, or turbines). This device will automatically run programs for, e.g., the cleaning and/or lubrication of the internal components with service oil, cleaning water/air spray channels with cleaning fluid and flushing with compressed air after external cleansing, but prior to sterilization. This process will improve performance and safety of the dental instruments. The unit is designed to accept different handpiece models, which are connected directly or via adaptors to the unit's processing chamber.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV100538440	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K071288	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius